BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 3850641 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-02374
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    September 20, 2013
    Report Date
    May 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD HIS SCS IPG REPLACED. AN SJM REP DID NOT MEET WITH THE PT PRIOR TO THE SURGERY ON (B)(6) 2014 OR HAVE ANY KNOWLEDGE OF THE IPG DEPLETION. THE PT'S IPG WAS REPLACED WITH A DIFFERENT MODEL IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317296 GENESIS SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3643 3434665

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other SCS LEAD: MODEL 3166 (X2)| IMPLANT DATE: